Ahmed 2014.
| Methods | RCT Setting: Hospital, 1 centre Country: Pakistan Duration of follow‐up: 8 weeks Duration of treatment: Not noted Funding source: Not reported Unit of analysis: Participant |
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| Participants | 60 participants Inclusion criteria: Grade I or II foot ulcer in person with diabetes (grading assessed using Meggitt‐Wagner scale and corresponds to absence of necrosis and osteomyelitis) of more than 4 weeks' duration. Adequate controlled diabetes with fasting blood sugar of 110 to 130 mg/dL on 2 consecutive days prior to recruitment in the study. Exclusion criteria: Patients with a history of hepatic or renal disease, those on corticosteroid therapy, and those with impalpable dorsalis pedis or posterior tibial arteries. Ulcer characteristics at baseline (size of ulcer, number of ulcers, duration of ulceration where reported) Group 1: All Wagner grade II ulcers; ulcer area 1107.53 SD: 486.5 Group 2: All Wagner grade II ulcers: ulcer area 1310.10 SD: 489.2 Infection status at baseline: Not reported |
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| Interventions | Group 1: (n = 30) Pyodine bath and saline and Vaseline gauze dressing Group 2: (n = 30) Phenytoin powder (from capsules, no information on concentration) applied in a thin, uniform layer plus pyodine bath and saline/Vaseline gauze dressing as for Group 1. The amount of powder depended on ulcer area. Additional treatment information: Dressings were changed daily or on alternate days depending on need. |
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| Outcomes | Primary review outcomes: None reported Secondary review outcomes: None reported |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The study patients were divided in two equal groups randomly by lottery method" Comment: Whilst limited information is presented, we assumed that the a lottery approach refers to a random sequence generation. |
| Allocation concealment (selection bias) | Unclear risk | Quote: "No information was provided on who conducted randomisation and if or how allocation was concealed" Comment: No information provided. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: No information provided. |
| Blinding of outcome assessment (detection bias) Wound healing | Unclear risk | Comment: No information provided. |
| Blinding of outcome assessment (detection bias) Infection/resolution of infection | Unclear risk | Comment: No information provided. |
| Blinding of outcome assessment (detection bias) Secondary outcomes | Unclear risk | Comment: No information provided. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: Flow chart reports 0 lost to follow‐up in either group. Comment: Assumed all participants followed up |
| Selective reporting (reporting bias) | Unclear risk | Protocol not obtained, all outcomes stated in methods reported. However, key outcomes not presented; unclear if these were measured. |
| Other bias | Low risk | None noted. |